202
Participants
Start Date
October 31, 2013
Primary Completion Date
January 31, 2016
Study Completion Date
April 30, 2016
DermACELL
Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).
GraftJacket
Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).
Conventional Care Dressings
"Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:~* If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.~* Hydrogels can also be used if the wound is in need of moisture.~* For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.~A secondary dressing may be desired to add either loft or cushion."
VA Pittsburgh Healthcare System, Pittsburgh
Wound Institute and Reseach Center, Dunmore
Andrews Research and Education Institute, Gulf Breeze
Institute for Advanced Wound Care, Montgomery
Rosalind Franklin University, CLEAR, North Chicago
Southern Arizona VA Health Care System, Tucson
ILD Research Center, Carlsbad
Limb Preservation Platform, Fresno
Limb Preservation Platform, Fresno
Center for Clinical Research, Castro Valley
Fairfield County Foot Surgeons, Norwalk
Boston Medical College, Boston
Lead Sponsor
LifeNet Health
INDUSTRY